Randomized Diagnostic Trial Comparing Ethylglucuronide and Ethanol
Primary Purpose
Alcohol Use Disorder
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ethyl glucuronide
ethanol
Sponsored by
About this trial
This is an interventional screening trial for Alcohol Use Disorder focused on measuring ethyl glucuronide, biomarker, diagnostic randomized trial
Eligibility Criteria
Inclusion Criteria:
- subjects had to be diagnosed of alcohol dependence according to DSM-IV, they had to undergo regular urine screening as part of their treatment and be willing to give informed written consent.
Exclusion Criteria:
- conditions rendering patients unable to complete study procedures
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
ethyl glucuronide
ethanol
Arm Description
subjects being screened with ethyl glucuronide
subjects being screened with ethanol
Outcomes
Primary Outcome Measures
ethyl glucuronide positive rate
Percentage of patients screening positive to EtG at study end in each group
descending of Etg positive rates in the Etg group
varying rate of EtG positive patinets in the intervention group during the study period
Secondary Outcome Measures
Full Information
NCT ID
NCT03276520
First Posted
September 7, 2017
Last Updated
September 8, 2017
Sponsor
Hospital Clinic of Barcelona
1. Study Identification
Unique Protocol Identification Number
NCT03276520
Brief Title
Randomized Diagnostic Trial Comparing Ethylglucuronide and Ethanol
Official Title
Filling the Gap Between Lab and Clinical Impact: an Open Randomized Diagnostic Trial Comparing Urinary Ethylglucuronide and Ethanol in Alcohol Dependent Outpatients.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
December 14, 2016 (Actual)
Primary Completion Date
July 1, 2017 (Actual)
Study Completion Date
July 31, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Clinic of Barcelona
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Background: Alcohol use disorders represent a major health burden. Efforts aiming at reducing alcohol-related harm include early detection of those with risky drinking habits as well detection of early relapse in patients with alcohol dependence who are detoxified and committed to abstinence. Recently, ethyl glucuronide has been proved to be a good biomarker for the detection of recent drinking. However, to date, no randomized diagnostic trial has tested its impact on drinking outcomes. The aim of this study was to assess, with a randomized design, the implications of ethyl glucuronide screening on alcohol outcomes, compared to screening with a low-sensitivity biomarker such as ethanol.
Methods: alcohol dependent outpatients were randomized to either 24 weeks of continuous screening with ethyl glucuronide or ethanol. Patients were aware of screening methods and results. After 24 weeks, all participants were screened with ethyl glucuronide. Self-reports were also gathered. A logistic regression model was performed comparing the rate of ethyl glucuronide positive results at study end between groups. Generalized estimating equations were performed to evaluate the descending rate of EtG positive patients in the EtG group, measured month to month.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder
Keywords
ethyl glucuronide, biomarker, diagnostic randomized trial
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
162 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ethyl glucuronide
Arm Type
Experimental
Arm Description
subjects being screened with ethyl glucuronide
Arm Title
ethanol
Arm Type
Active Comparator
Arm Description
subjects being screened with ethanol
Intervention Type
Diagnostic Test
Intervention Name(s)
ethyl glucuronide
Intervention Description
alcohol urine screening with ethyl glucuronide
Intervention Type
Diagnostic Test
Intervention Name(s)
ethanol
Intervention Description
alcohol urine screening with ethanol
Primary Outcome Measure Information:
Title
ethyl glucuronide positive rate
Description
Percentage of patients screening positive to EtG at study end in each group
Time Frame
after six months of ongoing urine screening
Title
descending of Etg positive rates in the Etg group
Description
varying rate of EtG positive patinets in the intervention group during the study period
Time Frame
six months of ongoing urine screening
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
subjects had to be diagnosed of alcohol dependence according to DSM-IV, they had to undergo regular urine screening as part of their treatment and be willing to give informed written consent.
Exclusion Criteria:
conditions rendering patients unable to complete study procedures
12. IPD Sharing Statement
Learn more about this trial
Randomized Diagnostic Trial Comparing Ethylglucuronide and Ethanol
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